- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07730866
Lower-Extremity Kinetic Chain Exercise Program for Achilles Tendinopathy (LEKC-AT)
Effects of a Lower-Extremity Kinetic Chain-Based Exercise Program on Postural Stability and Functional Outcomes in Patients With Achilles Tendinopathy: A Randomized Controlled Trial
Achilles tendinopathy is a common condition that causes pain, stiffness, and reduced function of the Achilles tendon. It can affect both physically active individuals and the general adult population, often making everyday activities and exercise more difficult. Exercise therapy is widely used as the primary conservative treatment; however, rehabilitation programs that focus only on the Achilles tendon may not address movement impairments involving the entire lower extremity.
This randomized controlled trial will evaluate a rehabilitation program based on the lower-extremity kinetic chain in adults with chronic mid-portion Achilles tendinopathy. Fifty participants will be randomly assigned to receive either a kinetic chain-based exercise program or a conventional rehabilitation program. Assessments will be completed before the intervention begins and again after it is finished.
The study will measure postural stability using the Biodex Balance System, foot and ankle function using the Foot and Ankle Outcome Score (FAOS), pain intensity using the Visual Analog Scale (VAS), and ankle range of motion using a goniometer.
The results will provide information on the effects of a rehabilitation approach that addresses the coordinated function of the lower extremity in people with chronic Achilles tendinopathy.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Background Achilles tendinopathy is one of the most common overuse conditions affecting the lower limb. It is characterized by activity-related pain, localized tenderness, reduced tendon function, and decreased tolerance to loading. These symptoms can limit daily activities, reduce participation in sports or exercise, and affect overall quality of life.
Exercise-based rehabilitation is considered the primary conservative treatment for Achilles tendinopathy. Traditional rehabilitation programs mainly focus on strengthening the Achilles tendon and calf muscles. However, factors such as muscle weakness, impaired neuromuscular control, altered movement patterns, and reduced postural stability elsewhere in the lower extremity may also contribute to symptoms and functional limitations.
The lower-extremity kinetic chain refers to the coordinated interaction of the foot, ankle, knee, hip, pelvis, muscles, fascia, ligaments, and other connective tissues during movement. Changes in the function of one part of this system may influence movement mechanics and loading across the Achilles tendon. A rehabilitation program that addresses the entire kinetic chain may therefore provide a broader approach to managing individuals with chronic Achilles tendinopathy.
Objective
The objective of this randomized controlled trial is to evaluate the effects of a lower-extremity kinetic chain-based exercise program on postural stability, pain intensity, ankle range of motion, and functional outcomes in patients with chronic Achilles tendinopathy.
Study Design
This prospective randomized controlled trial will include 50 adults diagnosed with chronic Achilles tendinopathy. Eligible participants will be randomly assigned to one of two groups:
Experimental Group: Lower-extremity kinetic chain-based exercise program added to conventional rehabilitation program.
Control Group: Conventional rehabilitation program only.
Outcome assessments will be performed before the intervention and immediately after the intervention by an assessor who is blinded to group allocation.
Outcome Measures
The study will assess the following outcomes:
Postural Stability: Overall Stability Index (OSI) will be measured using the Biodex Balance System.
Foot and Ankle Function: Assessed using the Foot and Ankle Outcome Score (FAOS).
Pain Intensity Level: Evaluated using the Visual Analog Scale (VAS). Ankle Range of Motion: Measured using a universal goniometer. Significance
This study will examine a rehabilitation approach that combines exercises targeting the Achilles tendon with exercises designed to improve the coordinated function of the entire lower extremity. The findings will provide information about the effects of this intervention on balance, pain, ankle mobility, and functional performance in patients with chronic Achilles tendinopathy. The results may help inform future rehabilitation strategies and contribute to the evidence supporting exercise-based management of this condition.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Cairo Governorate
-
Cairo, Cairo Governorate, Egipto
- Faculty of Physical Therapy, May University in Cairo
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Adults aged 18-45 years.
- Male and female participants.
- Clinical diagnosis of Achilles tendinopathy, confirmed by an orthopedic physician or physiotherapist and history of Achilles tendon surgery or lower-limb surgery within the previous 12 months.
- Symptoms (pain, stiffness, and impaired function) persisting for at least 3 months (chronic Achilles tendinopathy).
- Pain reproduced during tendon-loading activities (e.g., walking, running, hopping, or single-leg heel raises).
- Ability to walk independently without an assistive device.
- Body Mass Index (BMI) between 18.5 and <30 kg/m².
- Willingness to participate and provide written informed consent.
Exclusion Criteria:
- Patients with insertional Achilles tendinopathy or a partial/complete Achilles tendon rupture.
History of lower-limb fracture within the previous 12 months.
- Presence of systemic inflammatory, rheumatologic, or connective tissue disorders (e.g., rheumatoid arthritis, ankylosing spondylitis).
- Neurological disorders affecting balance, gait, or lower-limb function (e.g., stroke, Parkinson's disease, peripheral neuropathy, multiple sclerosis).
- Vestibular disorders or other conditions known to impair postural stability.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Lower-Extremity Kinetic Chain Exercise Group
Participants assigned to the experimental group will receive a supervised lower-extremity kinetic chain-based exercise program designed to improve lower-limb neuromuscular control, movement coordination, strength, flexibility, and postural stability.
The program includes progressive exercises targeting the foot, ankle, knee, hip, and trunk while addressing movement patterns throughout the lower-extremity kinetic chain, adding to the conventional exercise rehabilitation program.
The intervention will be delivered for 8 weeks.
|
The program includes progressive exercises targeting the foot, ankle, knee, hip, and trunk while addressing movement patterns throughout the lower-extremity kinetic chain
A standard rehabilitation program consisting of conventional therapeutic exercises commonly prescribed for chronic Achilles tendinopathy, including tendon-loading and lowe
|
|
Comparador activo: Conventional Exercise Group
Participants assigned to the comparison group will receive a conventional exercise rehabilitation program for chronic Achilles tendinopathy consisting of standard therapeutic exercises focused primarily on the Achilles tendon and calf musculature according to current rehabilitation practice.
The intervention will be delivered for the same treatment period as the experimental group.
|
A standard rehabilitation program consisting of conventional therapeutic exercises commonly prescribed for chronic Achilles tendinopathy, including tendon-loading and lowe
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
overall stability index
Periodo de tiempo: Baseline and immediately after completion of the 8-week intervention
|
The Overall Stability Index (OSI) will be measured using the Biodex Balance System to assess dynamic postural stability.
The OSI quantifies the variance of platform displacement from level in all directions during dynamic balance testing.
Lower OSI values indicate better postural stability, whereas higher values indicate greater postural instability.
|
Baseline and immediately after completion of the 8-week intervention
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Pain Intensity Level
Periodo de tiempo: Baseline and immediately after completion of the 8-week intervention
|
Pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS), where 0 represents "no pain" and 10 represents "worst imaginable pain."
Participants will rate their average Achilles tendon pain during tendon-loading activities.
|
Baseline and immediately after completion of the 8-week intervention
|
|
Foot and Ankle Function
Periodo de tiempo: Baseline and immediately after completion of the 8-week intervention
|
Foot and ankle function will be assessed using the Foot and Ankle Outcome Score (FAOS), a validated patient-reported outcome measure evaluating pain, symptoms, activities of daily living, sport and recreation function, and foot- and ankle-related quality of life.
Higher scores indicate better function and fewer symptoms.
|
Baseline and immediately after completion of the 8-week intervention
|
|
Ankle Joint Range of Motion
Periodo de tiempo: Baseline and immediately after completion of the 8-week intervention
|
Active ankle dorsiflexion, plantarflexion, inversion, and eversion range of motion will be measured in degrees using a universal goniometer according to standardized measurement procedures.
Greater range of motion indicates improved ankle mobility.
|
Baseline and immediately after completion of the 8-week intervention
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- AT-RCT
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .